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Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy

NCT06660940 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2024-10-28

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy of Keluoxin Capsules for the treatment of diabetic kidney disease (DKD) and diabetic retinopathy (DR) compared to placebo on a conventional treatment basis.

Conditions

Interventions

DRUG

Keluoxin Capsules

Treatment period (52 weeks):Keluoxin Capsules, 4 capsules/time, swallow with warm water after meals, 3 times/day

DRUG

Keluoxin Capsule Simulants

Treatment period (52 weeks):Keluoxin Capsule Simulants, 4 capsules/time, swallow with warm water after meals, 3 times/day

DRUG

Irbesartan

1. Lead-in period (2-4 weeks): Irbesartan 75-300mg/d, QD; 2. Treatment period (52 weeks): Irbesartan 75-300mg/d, QD

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Xiangmei chen · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2027-10-31
Completion
2027-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660940 on ClinicalTrials.gov